NCT03877445

Brief Summary

Melasma is a fairly common condition resulting in hyperpigmented macules on the face. Melasma is difficult to treat and has a significant negative impact on the patient's quality of life. Melasma is worsen when exposed to high energy visible light (blue and violet light) of the solar spectrum. Blue light emitted by LED screens from computers, tablets, televisions and even mobile phones is currently suspected (via media channels) to induce harmful effects on the skin, including pigmentation and photoaging. These screens, however, emit much lower irradiances than those of the solar spectrum, and the probability that these irradiances impact the skin is very low. The objective of the study is to assess the effect of blue light emitted by computer/television screens on the intensity of melasma pigmentation. To do this, it is proposed to use maximized conditions that could be encountered in normal daily life, namely a simulation of blue light exposure (420-490nm) at 20 cm from a laptop LED screen, 8 hours a day for 5 days. Since it is not proposed to expose a person for 8 hours a day, a solar simulator with appropriate filters will be used to emit a spectrum of between 420 and 490 nm with a compatible intensity for an acceptable duration of exposure (around 30 minutes a day). Twelve patients will be included in the study and exposed on a half-face from Day1 to Day5. The other half-face will serve as unexposed control. The effect of blue light on the melasma lesions will be assessed from Day 1 to Day 6 using chromametry and a modified MASI on standardized photographs. A final evaluation visit will be performed at Day 15.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 15, 2019

Completed
27 days until next milestone

Study Start

First participant enrolled

April 11, 2019

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 11, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 22, 2019

Completed
Last Updated

March 24, 2026

Status Verified

March 1, 2026

Enrollment Period

Same day

First QC Date

March 13, 2019

Last Update Submit

March 20, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Evaluate the effect of blue light emitted by computer / television screens on the intensity of pigmentation of melasma by Melasma Area and Severity Index scale

    15 days

Secondary Outcomes (2)

  • Evaluate the tolerance and the possible undesirable effects induced by the exposure in blue light with Melasma Area and Severity Index scale

    15 days

  • Evaluate the effect of blue light emitted by computer / television screens on the intensity of pigmentation of healthy skin by chomametry

    15 days

Study Arms (2)

Melasma Group exposed left half-face by ORIEL solar simulator

OTHER

Twelve patients will be included in the study and exposed on a half-face from Day1 to Day5. The other half-face will serve as unexposed control.

Device: exposition half-face

Melasma Group exposed right half-face by ORIEL solar simulator

OTHER

Twelve patients will be included in the study and exposed on a half-face from Day1 to Day5. The other half-face will serve as unexposed control.

Device: exposition half-face

Interventions

Patients will be included in the study and exposed on a half-face from Day1 to Day5. The other half-face will serve as unexposed control. The effect of blue light on the melasma lesions will be assessed from Day 1 to Day 6 using chromametry and a modified Melasma Area and Severity Index on standardized photographs

Melasma Group exposed left half-face by ORIEL solar simulatorMelasma Group exposed right half-face by ORIEL solar simulator

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female patient, 18 years of age and older, phototype II to V on the Fitzpatrick scale
  • Patient with a clinically diagnosed diagnosis of melasma.
  • Patient without a serious medical history and declared fit to participate in the medical visit.
  • Patient who has signed a written informed consent form before any action related to the study is initiated.
  • If the patient is able to procreate, she should use reliable contraception (contraceptive pill, contraceptive implant, intrauterine contraceptive device, bilateral tubal ligation / section, condoms), and agree not to change contraceptive status for at least one month before the start of the study and throughout the duration of the study.

You may not qualify if:

  • Women who are pregnant or breastfeeding or who have planned a pregnancy during the course of the study.
  • Patient with another pigment condition on the face.
  • Patient who took systemic or topical photosensitizing treatments during the month preceding the first day of the study (1 month or 5 half-lives, the longest possible duration),
  • Patient with a history of photodermatoses.
  • Patient spending more than 3 hours a day in front of a screen (computer, LED TV, tablet, phone etc ...) for professional or private reasons.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre de Pharmacologie Clinique Appliquée à la Dermatologie

Nice, France

Location

Related Publications (1)

  • Duteil L, Queille-Roussel C, Lacour JP, Montaudie H, Passeron T. Short-term exposure to blue light emitted by electronic devices does not worsen melasma. J Am Acad Dermatol. 2020 Sep;83(3):913-914. doi: 10.1016/j.jaad.2019.12.047. Epub 2019 Dec 27. No abstract available.

MeSH Terms

Conditions

Melanosis

Condition Hierarchy (Ancestors)

HyperpigmentationPigmentation DisordersSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Thierry PASSERON, MD, PhD

    Centre Hospitalier Universitaire de Nice

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2019

First Posted

March 15, 2019

Study Start

April 11, 2019

Primary Completion

April 11, 2019

Study Completion

July 22, 2019

Last Updated

March 24, 2026

Record last verified: 2026-03

Locations